AKRA TEAM GmbH Market Research Report
Company Overview
Name and Mission
AKRA TEAM GmbH
AKRA TEAM is a highly specialized consultancy dedicated to supporting various stakeholders in bringing medical devices, in-vitro diagnostics, and combination device products to market efficiently and in compliance with complex legal obligations. The company aims to make a significant impact in ensuring that patients have access to safe and effective medical devices in a timely manner.
Founding Information
Founded: 2021
Founder: Dr. Bassil Akra
Key People
- Dr. Bassil Akra - Founder and Executive Consultant
- Dr. Andrew Gibson - Team Leader and Senior Consultant
- Dr. Fabienne Neibecker - Senior Consultant
- Muna Kebede - Senior Consultant
- Matthias Fink - Senior Clinical Consultant
- Dr. Susanna Kerschl - Senior Consultant
- Dr. Leslie Hammermüller - Senior Consultant
- Dr. Ulla Gertig - Senior Consultant
- Ema Omeragić Zaimović - Senior Consultant
- Dr. Anna Spehl - Senior Consultant
- Dr. Amith Vijayakumar - Senior Clinical Consultant
- Lawrence Yeh - Quality Manager and Senior Consultant
- Hilola Hakimova - Junior Consultant
- Dr. Susanne Gerbl-Rieger - Senior Consultant
- Monica Ceruti - Management Assistant
- Andrea Beaujean - Marketing Manager
Headquarters
- Germany: Am Penzinger Feld 17a, 86899 Landsberg am Lech
- USA: 250 Park Avenue, 14th Floor, Office 1475, New York, NY 10177
Employees
No information is available.
Revenue
No information is available.
Company Specialization
AKRA TEAM is known for its consultancy services focusing on regulatory affairs in the healthcare sector. They assist medical device, in-vitro diagnostic, and combination device companies in achieving compliance with regulatory requirements, providing expert guidance and support throughout the process.
Products and Services
Product Offerings
Services Include:
- Regulatory strategy preparation
- Coaching and project management
- Quality Management System development
- Drafting of procedures and templates
- Technical documentation including clinical or performance evaluation
- Readiness checks, internal and supplier audits
- Selection of notified bodies and designated competent authorities
- Communication with regulators and notified bodies
- Support during clinical (performance) evaluation consultation
Product Descriptions & Key Features
- Regulatory Strategy Preparation: Tailored strategies to ensure compliance with EU MDR and IVDR.
- Quality Management System Development: Implementation of QMS to align with regulatory standards.
- Technical Documentation: Comprehensive support in drafting technical documentation necessary for regulatory submissions.
- Notified Body Selection: Assistance in selecting appropriate notified bodies to enhance the efficiency of product certification.
- Communication with Regulators: Facilitating effective communication channels with regulatory agencies to expedite approvals.
Recent Developments
Recent Company Developments
- Awards:
- Awarded as “Arbeitgeber der Zukunft” (Employer of the Future) in December 2023.
- Received the TOP CONSULTANT award in June 2023 for being among the best consultants for medium-sized businesses.
New Products or Features
No specific new products or features have been launched recently that are mentioned in the data provided.
New Partnerships
AKRA TEAM has established partnerships with several organizations to augment its service offerings:
- Obelis: Collaborating on MDR & IVDR expertise.
- MDlaw: Partnered for regulatory requirements monitoring and changes.
- meddevo: Partnering for technical documentation technology solutions.
- DistillerSR: Working together for literature review automation and management.
- InSilicoTrials: Collaboration towards digital simulation for healthcare innovation.
- Meditrial: Joint efforts for clinical research organization services.
- Dr. Ebeling & Assoc. GmbH: Cooperation in medical writing and vigilance services.
- Use-Lab GmbH: Combined efforts in usability engineering and user interface design.
Engagement and Contact
AKRA TEAM encourages potential clients to contact them for support, book meetings, or engage in training sessions, particularly for regulatory affairs guidance. They maintain two offices for seamless client engagement and service delivery.
- Contact Information:
- Phone: +49 8191 96 34 783
- Email: info@akrateam.com
Conclusion
AKRA TEAM GmbH is a pivotal player in the healthcare consultancy field with a core focus on regulatory compliance, assisting stakeholders to meet stringent requirements while fostering innovations in medical device technology. With a demonstrated commitment to excellence, underscored by recent awards, AKRA TEAM fosters strategic partnerships to expand their expertise and deliver unmatched regulatory consultancy services.
